Executive Director Clinical Development - Paris, France - Daiichi-Sankyo Europe

Description

The position:

• Based in Europe, this position is fulltime functionally part of the Global Clinical Development team. The individual will provide clinical leadership and direct accountability to large oncology program(s), with one or more indications, multiple studies, including large complex, global pivotal study(ies), for one or more products in either development for launch and or early or translational development stage.
• He/she will provide clinical leadership to the development and delivery of differentiated clinical strategy for existing assets life cycle management plan or for new assets, regulatory submission and review, scientific disclosure and publications, translational development and science in coordination with the translational medicine group.
• This position will play in key role, as applicable, interfacing with CRO clinical monitor teams and ensure sponsor clinical oversight throughout the conduct of the study(ies).
• This position be providing clinical representation to Health Authorities worldwide as needed, including in Europe as warranted.
• Beyond the projects for which he/she is directly involved and accountable, the position holder will also play, to an extent, a special "liaison/interface"' role between global R&D organization and the EU team in order to bring global expertise and insights closer to the EU HCPfacing teams.

Key responsibilities:

• Study Strategy: Provides the strategic direction and crossfunctional leadership to Biostatistics, Data Management, and clinical operations for Electronic Data Captures, edit checks, data quality listings, Statistical Analysis Plan (SAP), Reviews patient population and protocol compliance for consistency with study strategy, contributes to development of biomarker strategy in collaboration with translational research group, collaborates with Key External Experts (KEEs) to refine study plans; Prepares and participate in regulatory agency meetings, when applicable.
• Study planning and execution: Provides input on major milestones of trial, clinical trial plan and contingency planning, Updates management on potential risks to study deliverables, Provides input on ICF creation, Oversees recruitment, retention; establishes and implement contingency plans for shortfalls, Consults & recruits members for Independent Data Monitoring Committee (IDMC) and/or adjudication committee setup; Interacts with KEEs and Investigators to plan study and monitor completion.
• Study outputs: Drafts responses to Institutional Review Committees, and Health Authorities, Collaborates to ensure appropriate biomarker, PK / PD measurements, Reviews emerging

- clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead e.g. review Tables/Figures/Listings (TFLs) before database lock, and quality check of data, Works with Biostatistics, Data Management, and clinical operations to ensure SAP updates.

• Medical monitoring planning For large Phase 2 or Phase 3 studies: Reviews, edits, contributes to, or approves and updates medical monitoring plan, Develops Serious Adverse Events flow plan in conjunction with Clinical Safety, Defines medical monitoring oversight component of study, Sets up IDMC and/or adjudication committee; reviews and edits IDMC/Adjudication charters, Develops medical content for protocol profile, protocol and amendments; Directs CRO medical monitor activities; or act as Regional sponsor medical monitor for Phase 3 study.
• Medical surveillance: Collaborates with Clinical Safety to ensure monitoring / reporting of Adverse Events, Reviews safety reports/data during study conduct, Provides and documents oversight of medical monitoring activities, Reviews data before database lock from medical perspective, assist in creation of TFLs, Reviews, oversees creation of patient narratives, Provides medical direction to medical writer for the clinical study report and submission documents.
• Regional interface: represents Europe's specific needs to the rest of Global Development team as input to the development and execution of global clinical development plan.
• External collaboration: Develops, contributes to, or leads external advisory panels to advise on study strategy, design, and conduct; Interacts with KEEs for indication specific advice; Leads broad collaboration with KEEs or major institutions.
• Scientific, Program related: Contributes to early development plan and contributes to overall development strategy for early development programs as needed; Contributes to developing program biomarker strategy; Achieves endorsement for plan by function and team; Interprets and react accordingly to new preclinical/clinical data(e.g.; Go/No Go decisions, reprioritization, etc.).
• Additional nonstudy related activities: involvement in Business Development activities for late stage compounds inlicensing and acquisitions on individual due diligence activities; Contributor to therapeutic area strategy